Sirona Biochem Corp . (TSXV: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona ") is pleased to provide the following update to shareholders.
We continue to make substantial progress with core deliverables.
Rodan + Fields (R+F) is completing the final stages in preparation to launch one of their newest skin care products incorporating TFC-1067. The dates are tightly guarded at this time and shareholders will be updated as soon as we are able to do so. We can report that everything is still progressing on schedule. As this will be our first project to reach commercial sales, we are looking forward to a successful launch.
Manufacturing of commercial quality TFC-1067 is ongoing in both China and France and shipments have been completed from both countries to the USA . As is the case with most new manufacturing, we continue to invest in optimizing the process. The development of an optimal production is an initial investment and a necessary condition to ensure we can sustainably serve a growing demand.
Our second clinical trial for TFC-1067, utilizing a higher dose, has been successfully completed and preliminary results have been received from Dermscan. We expect the final report within 4 weeks at which time we will review the results with our pharmaceutical partner ( see news Oct 2020 ). We anticipate being able to release a portion of the results that are independent of our partner after a period of due diligence.
Several multinational companies have approached Sirona with interest in TFC-1067. Once the first product is available for purchase and we can release the latest data, we anticipate that number to grow. The data package now contains many in vitro studies, clinical safety data, two clinical trials and manufacturing. Additionally, we have a partner who independently tested the product providing further support for its performance.
After completing our due diligence, we made the decision not to pursue an agreement with HuaxiPharm. They have experienced internal challenges and delays and we do not feel their goals align with Sirona at this time. We have been working on developing a relationship with another company that can manage all aspects of commercialization of TFC-1067 in China . Our board and senior team are in regular discussion with this company on moving forward with an agreement. Extensive due diligence has already occurred.
TFC-039 for a type 2 diabetes pharmaceutical has completed another major phase in development and material information is pending.
TFC-039 for animal health continues to progress. We are in discussions with two international companies on this project and as such it has taken more time than expected to coordinate. Sirona and its consultants have structured and negotiated this unique partnership. We have closed binding terms on one side of this deal with the partner and we anticipate the other partner closing soon. Until such time that both partners have agreed to all terms, the details must remain confidential.
In addition, the team at TFChem are currently investigating further indications for TFC-039.
Our team has recently completed further studies for our anti-aging project to analyze our library of compounds and determine a lead. While we had previously done studies on some of these compounds, the lab was successful in developing further compounds for the library which we believe may have additional potential. These compounds must be patented and to do so, it is a requirement to fulfill a set of in-vitro studies. The studies are now complete, and we can begin the next steps of preparing a lead for further investigative studies in safety prior to the clinical trial. The project was introduced to several companies at BIO JPM ( https://www.bio.org/events/bio-partnering-jpm ) and we are developing the information package to share with them. We also anticipate further discussions with our current partners about this project.
With recent developments in other projects as well as the lab's dedication to scale-up and managing the clinical trials of this project, the antiviral project remains less of a priority at the moment, but very much on the agenda for 2021 and 2022. We will update as progress is made.
Sirona continues to thrive in a world which has become increasingly virtual and has been conducting business daily on four continents. With a well-seasoned and experienced team, including multiple locally based consultants, travel has become unnecessary to maintain our progress. We will continue to support and grow our pipeline technology developed by our dedicated team of TFChem scientists based in Rouen, France .
We also continue to focus our efforts to create significant value for our shareholders. We realize that some investors had hoped for more progress. However, once again, we are moving forward and we are very confident that we will reach further significant milestones and continue to develop Sirona as a commercially successful company.
Dr. Howard Verrico, CEO
About Sirona Biochem Corp.
Sirona Biochem is a cosmetic ingredient and drug discovery company with a proprietary platform technology. Sirona specializes in stabilizing carbohydrate molecules with the goal of improving efficacy and safety. New compounds are patented for maximum revenue potential.
Sirona's compounds are licensed to leading companies around the world in return for licensing fees, milestone fees and ongoing royalty payments. Sirona's laboratory, TFChem, is located in France and is the recipient of multiple French national scientific awards and European Union and French government grants. For more information, please visit www.sironabiochem.com .
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Sirona Biochem cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. Forward-looking statements are only predictions based upon current expectations and involve known and unknown risks and uncertainties. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of release of the relevant information, unless explicitly stated otherwise. Actual results, performance or achievement could differ materially from those expressed in, or implied by, Sirona Biochem's forward-looking statements due to the risks and uncertainties inherent in Sirona Biochem's business including, without limitation, statements about: the progress and timing of its clinical trials; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing its products; unexpected adverse side effects or inadequate therapeutic efficacy of its products that could delay or prevent product development or commercialization; the scope and validity of patent protection for its products; competition from other pharmaceutical or biotechnology companies; and its ability to obtain additional financing to support its operations. Sirona Biochem does not assume any obligation to update any forward-looking statements except as required by law.
SOURCE Sirona Biochem Corp.
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